Breast CancerNCT05394194
Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer
An observational study of Breast Cancer, run by Sohag University.
Trial summary
We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2022to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 30 Female patients who will present to clinical Oncology department with early breast cancer, with pathological staging ≤ T2N0M0 and are operated by conservative breast surgery will be included in our current study.
Who may be able to join
- left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities
Who cannot join
- locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.
Trial locations and contacts
No sites are listed yet.
About this study
We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.
- Conditions
- Breast Cancer
- Keywords
- computer assisted, radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3DCRT group | In this plan, we will create plans using three dimensional conformal radiotherapy, evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. | |
| IMRT group | In this plan, we will create plans using intensity modulated radiotherapy (IMRT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. | |
| VMAT plan | In this plan, we will create plans using volumetric modulated radiotherapy (VMAT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of coverage of planned target volume(PTV) among the three plans.
PTV coverage in dose is compared among the three plans.
Measured: 1 year
Comparison of doses to organs at risk among the three plans.
mean dose of the heart, lung volume receiving 20Gy, esophageal doses will be compared among the three plans
Measured: 1 year
Secondary outcomes (1)
Comparison of target homogeneity among the three plans.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start20 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaymaa Abdelghaffar, Sohag University
- Investigators
- Alshaymaa Abdelghaffar, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394194
- Sponsor's protocol ID
- Soh-Med-22-05-24
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT05394194
- Acronym / sponsor ID
- Soh-Med-22-05-24
- Conditions
- Breast Cancer
- Keywords
- computer assisted, radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3DCRT group | – | –In this plan, we will create plans using three dimensional conformal radiotherapy, evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. |
| IMRT group | – | –In this plan, we will create plans using intensity modulated radiotherapy (IMRT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. |
| VMAT plan | – | –In this plan, we will create plans using volumetric modulated radiotherapy (VMAT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 Female patients who will present to clinical Oncology department with early breast cancer, with pathological staging ≤ T2N0M0 and are operated by conservative breast surgery will be included in our current study.
Key inclusion criteria (1 listed)
- left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities
Key exclusion criteria (1 listed)
- locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of coverage of planned target volume(PTV) among the three plans.
Time frame: 1 year
PTV coverage in dose is compared among the three plans.
Comparison of doses to organs at risk among the three plans.
Time frame: 1 year
mean dose of the heart, lung volume receiving 20Gy, esophageal doses will be compared among the three plans
1 secondary outcome
Comparison of target homogeneity among the three plans.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshaymaa Abdelghaffar, PhD principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa Abdelghaffar, PhD (01006828975 ext. 002, alshimaaahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of coverage of planned target volume(PTV) among the three plans. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.